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Medical Device Certification Specialist jobs in Ontario

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    • Minimum 3 years of Regulatory Affairs experience, preferably within the medical device industry.
    • Strong knowledge of FDA regulations, medical device regulatory…
    • As a skilled specialist, the incumbent identifies and executes validation work based on business need, manages small projects end-to-end, coordinates with…
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    • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
    • Experience in regulatory affairs through internship role/s, preferably in the medical device industry.
    • Directs or performs coordination and preparation of…
    • Experience in the medical device or pharmaceutical industry, with a focus on surgical products is an additional asset.
    • Often 2-3 nights a week away from home.
    • 5+ years of experience working within a regulated quality environment, preferably in medical device development and commercialization.
    • Minimum of 5-7 years of directly related Regulatory Affairs experience in medical devices required.
    • The Staff Specialist of Regulatory Affairs reports directly…
    • Minimum 7+ years of Regulatory Affairs experience within the medical device industry, including experience with Class III and Class IV medical devices.
  • View similar jobs with this employer
    • Acts in compliance to drug, medical device, and local regulations.
    • The Healthcare Quality Assurance (QA) Specialist overall Quality System status of the…
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Job Post Details

Regulatory Affairs Specialist
ADECCO
·
3.7
Toronto, ON
$35 an hour
Temporary, Contract
Apply now

Job details

$35 an hour
Dental care
Temporary, Contract
Monday to Friday
Toronto, ON

Full job description

Adecco is currently hiring a Regulatory Affairs Specialist for an exciting opportunity within the medical device industry in Toronto, ON.

As a Regulatory Affairs Specialist, you will support the development, submission, and maintenance of regulatory filings while providing guidance throughout the product lifecycle. You will collaborate with cross-functional teams to ensure products meet regulatory requirements and can be successfully commercialized in domestic and international markets.

  • Pay Rate: $35/hour

  • Location: Toronto, ON

  • Shift: Monday to Friday

  • Job type: Temporary 6 months | Full-time

  • Vacancy Status: This posting is for an existing vacancy.

Here's why you should apply:

  • Paid weekly accurate and on time

  • Strong health and safety programs

  • Medical and dental benefits once qualified

  • Free training programs

  • New and quicker onboarding process

Responsibilities:

Regulatory Submissions & Compliance

  • Prepare, assemble, submit, track, and maintain regulatory filings for medical device products.

  • Support FDA 510(k) submissions and other regulatory applications.

  • Research and evaluate regulatory pathways for new and modified products.

  • Assess regulatory requirements and ensure compliance throughout the product lifecycle.

  • Evaluate the regulatory impact of product, process, and labeling changes.

Regulatory Strategy & Product Development

  • Support the development of regulatory strategies for new product development projects.

  • Provide regulatory guidance to cross-functional teams during product development and commercialization.

  • Review product labeling, package inserts, promotional materials, and advertising for regulatory compliance.

  • Assist with international product registrations and market access initiatives.

Stakeholder & Agency Communication

  • Communicate with regulatory authorities, distributors, foreign governments, and internal stakeholders.

  • Respond to regulatory inquiries and support regulatory audits and inspections.

  • Maintain regulatory documentation and support compliance reporting activities.

Qualifications and Skills:

  • Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, Regulatory Affairs, or a related scientific/technical field.

  • Minimum 3 years of Regulatory Affairs experience, preferably within the medical device industry.

  • Strong knowledge of FDA regulations, medical device regulatory requirements, and submission processes.

  • Experience preparing or supporting FDA 510(k) submissions.

  • Knowledge of EU MDR and other international regulatory requirements.

  • Strong technical writing, communication, organizational, and project management skills.

  • Ability to manage multiple priorities and work effectively with cross-functional teams.

  • Experience in orthopedics or medical devices is a strong asset.

  • Must be legally eligible to work, and reside in Canada

Are you interested in this position? Apply now! Our dynamic team of recruiters will reach out if you qualify for this role.

At Adecco our purpose is simple: to make the future work for everyone. We live our values, Passion, Collaboration, Inclusion, Courage, and Customers at Heart, by fostering a workplace where diversity is celebrated and every voice matters. We encourage applications from individuals of all backgrounds and identities. Together, we're making the future work for everyone.

Please reach out to learn how the Aspire Academy can upskill you into your next role.

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